Current jobs related to Pharmacovigilance Scientist - Cambridge, Cambridgeshire - Lifelancer
-
Senior Regulatory Scientist
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom TN United Kingdom Full timeSocial network you want to login/join with:Senior Regulatory Scientist (Clinical Trial Submissions), Cambridgecol-narrow-leftClient:VCLSLocation:Cambridge, United KingdomJob Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:b9e345cfca12Job Views:8Posted:26.04.2025Expiry Date:10.06.2025col-wideJob Description:Senior Regulatory Scientist...
-
Senior Safety Associate
1 week ago
Cambridge, United Kingdom CK GROUP Full timeCK Group are recruiting for a Senior Safety Associate to join a biopharmaceutical company at their site based in Cambridge on a on a contract basis for 12 months.**Salary**: £25.64 ph PAYE or £33.48 ph UMB**Company**: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing,...
-
Senior Associate Global Safety
2 days ago
Cambridge, United Kingdom CK GROUP Full timeCK Group are recruiting for a Senior Associate Global Safety to join a biopharmaceutical company at their site based in Cambridge on a contract basis for 12 months. **Salary**: Up to £26.00 PAYE or £34.00 UMBRELLA **Company**: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering,...
-
Senior Associate Global Safety
1 week ago
Cambridge, United Kingdom CK GROUP Full timeCK Group are recruiting for a Senior Associate Global Safety to join a biopharmaceutical company at their site based in Cambridge on a on a contract basis for 12 months. **Salary**: Per Hour £25.64 PAYE or £33.48 UMB **Company**: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering,...
-
Global Clinical Program Lead
1 week ago
Cambridge, United Kingdom AstraZeneca Full timeAt AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicine is about being entrepreneurial - finding those moments and recognizing their potential. Big success can come from seeing potential in...
Pharmacovigilance Scientist
1 month ago
Job Title: Pharmacovigilance Scientist (Director Senior Director)
Job Location: Cambridge UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: Director
Company OverviewAt Merus we are advancing leadingedge targeted treatments using our pioneering multispecific antibody generating technologies Multiclonics to address the unmet needs of patients with various types of cancer. Working at Merus gives you the opportunity to contribute to our mission of closing in on cancer. We care deeply about improving patients' lives. This is why we are committed to getting this right with a global and diverse team of highly qualified professionals. We have bold aspirations because the need is great and the patients are waiting. Join us and make an impact.
Key Responsibilities
Your Role
Merus is seeking a Sr/Director Pharmacovigilance (PV) Scientist who will be accountable for overall PV science support for pharmacovigilance department at Merus which includes working in collaboration with the Global Safety Physician(s) to lead signal detection activities conducted in the safety governance model within the company. This includes review of adverse event and laboratory data as applicable Serious Adverse Events reported in clinical trials and literature relevant to the products assigned. The ideal candidate will play a critical role in further developing and enhancing PV processes and procedures relative to the PV scientist role.
The position reports to the VP of Pharmacovigilance/Head of Safety and is remote based but will be affiliated with the Cambridge MA office location and will be expected to travel to the office as needed for meetings and other business needs.
In This Role You Will
- Leads PV Scientist activities of crossfunctional project teams for developmental compounds and/or marketed products at Merus.
- Works in collaboration with the Global Safety Physician to develop maintain oversee and execute the comprehensive safety surveillance and signal detection plan for assigned products.
- Author and contribute safety sections and other relevant content to Investigator Brochures Protocols Informed Consents and Clinical Study Reports.
- Leads the collaboration with Safety and Clinical representatives and authors the Reference Safety Information (RSI) for assigned products based on the developed benefitrisk profile.
- Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs PSURs DSURs) according to processes and timelines.
- Authors/provides strategic leadership to regulatory submissions for new products formulations or indications (NDA/BLA MAA) in partnership with the Global Safety Physician and other functional experts.
- Contributes to pharmacovigilance and risk management planning for Merus products including preparation of the safety aspects of Risk Management Plans with the applicable License Partners as appropriate and REMS if applicable.
- Supports multidisciplinary Safety Management Team and escalation of all relevant safety matters to the appropriate decisionmaking level providing appropriate proposals for solutions based on analysis of the available information and in collaboration with the Global Safety Physician.
- Additional projects as assigned
- Participates in PV audits inspections CAPA activities as required
- Contributes to drug safety departmental policies and procedures that address signal detection and management safety governance and periodic reporting as applicable.
Your Profile
We are looking for a candidate with:
- Bachelor's in sciences/pharmacy/nursing degree or related field Bachelor's degree in healthcare related discipline or equivalent RN R.Ph. or Pharm D. degree is highly preferred
- 8 years of proven pharmacovigilance experience preferably in oncology
- Experience working in safety &/or scientific activities in the setting of Product Safety Team/Safety Management Team model
- Experience with Early and Late Phase development clinical trials and safety surveillance and signal detection processes
- High EQ with demonstrated skills and experience fostering a positive culture within a PV organization
- General knowledge and understanding of US and EU PV requirements e.g. US Code of Federal (CFR) regulations European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines
- Experience and extensive working knowledge of MedDRA and proprietary safety databases PV processes for individual case medical review signal detection and evaluation aggregate data assembly review and reporting as well as clinical study safety management
- Experience with the compilation writing and reviewing of safety documents such as DSURs IB PBRERs/PADERs responses to Health Authority requests submission documents and safety labels
- Previous MAA/BLA experience including contributing to the preparation and authoring of the safety related aspects of the Common Technical Document
- Experience with audits and inspection
- Strong relationship building skills with ability to interact effectively in a multifunctional multicultural growing organization
- Strategic thinking strong organizational and analytic skills project management excellent verbal written communication skills attention to detail
Our offer
We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus you'll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off we offer a highly competitive total rewards package (benefits and compensation) training that is tailored to your individual development and career opportunities that match your ambitions. Most importantly you'll have the chance to help us close in on cancer – everything you do matters at Merus.
Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.
For more details and to find similar roles please check out the below Lifelancer link.
/jobs/view/5b7663c7b5e376f163e54b0c0400441e
Key Skills
Laboratory Experience,Immunoassays,Machine Learning,Biochemistry,Assays,Research Experience,Spectroscopy,Research & Development,cGMP,Cell Culture,Molecular Biology,Data Analysis Skills
Employment Type : Full Time
Experience: years
Vacancy: 1
